Posted on: November 20, 2022
Job Summary -The Analytical Scientist will be part of a team of
drug development professionals responsible for the continued
development and regulatory approval of thin film drug products
containing a wide range of therapeutic compounds.
- Hands-on laboratory analysis of R&D drug substance and drug
- Method development, method transfer and validation of
analytical methods developed in-house or from client.
- Provide analytical support during pre-formulation, formulation
development and manufacture of prototype formulations, clinical
trial materials and process scale-up.
- Perform characterization, release and stability testing of raw
material and drug product samples for conformance to
- Prepare and update/review SOPs for the analytical
- Observe and maintain compliance with applicable DEA and safety
regulations, cGLP/GMP guidelines, and Aquestive policies and
- Interact in a team atmosphere, providing expertise in general
- Troubleshooting and repair of minor problems in analytical
- Responsible for laboratory work area housekeeping.
- Assist with raw data review, analysis, report writing and
laboratory investigations (OOT/OOS).
- Ensure that responses to regulatory inquiries are conducted in
accordance with regulatory -guidelines and in consideration of
business implications. -
- BS/MS in Chemistry. -
- Minimum 3 - 5 years of pharmaceutical experience in an R&D
analytical laboratory supporting small molecule, protein and
peptide development programs
- Strong analytical skills, proven experience in wet chemistry,
HPLC, Dissolution, KF, GC and spectrophotometry
- Thorough knowledge of cGMPs, compendia requirements, FDA and
- Experience working with and interpreting regulatory documents
such as CFRs, FDA and ICH Guidance documents
- Excellent written and oral communication skills with an ability
to prepare and present concise technical data reports to
- Prior experience with FDA/EMA inspections and audits a
- Proficiency in standard office software (MS Word, Excel,
- Must be detail oriented and organized with excellent
Keywords: Comrise, Elizabeth , Analytical Scientist, Other , Warren, New Jersey
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